CN101291697B - Vented drug reservoir unit - Google Patents
Vented drug reservoir unit Download PDFInfo
- Publication number
- CN101291697B CN101291697B CN2006800386481A CN200680038648A CN101291697B CN 101291697 B CN101291697 B CN 101291697B CN 2006800386481 A CN2006800386481 A CN 2006800386481A CN 200680038648 A CN200680038648 A CN 200680038648A CN 101291697 B CN101291697 B CN 101291697B
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- Prior art keywords
- storage unit
- storage chamber
- housing
- transdermal
- unit
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
- A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T137/00—Fluid handling
- Y10T137/0318—Processes
- Y10T137/0324—With control of flow by a condition or characteristic of a fluid
Abstract
A reservoir unit (200) is provided comprising a housing (201) in which a reservoir (250) with a transparent portion (251) is arranged, the housing comprising a window (203) allowing a portion of the reservoir to be inspected. The reservoir unit is adapted to be moved from a first ''cold'' condition to a second ''warm'' condition with no visible water condensing on the interior surface of the window portion. Further, a vent (210, 211) is adapted to provide pressure equalization between the interior of the housing and the exterior. In this way it is possible to perform visual inspection of the reservoir at all times without being confused by dew or condensed water drops, e.g. when a prefilled reservoir unit containing a drug which requires storage at a given low temperature, as is the case for insulin-containing drugs, is taken out in ambient temperature.
Description
Technical field
Present invention relates in general to comprise the storage unit of liquid medicine, this storage unit comprises the state that allows to check medicine, such as but not limited to the fibrillation (fibrillation) of checking insulin.
In the present disclosure of the invention, great majority relate to be by inject or insulin injection to treatment of diabetes, yet this only is a kind of exemplary purposes of the present invention.
Background technology
Be used for medicine is injected patient's portable explosive-feeding processing device for well-known, and this device generally comprises a storage chamber, it is suitable for comprising a kind of liquid medicine, this device has the outlet that is in the fluid connected state with the injection needle of hollow, and discharger, this discharger passes the skin of object with cause storage chamber discharge medicine, by hollow pinhead.This explosive-feeding processing device promptly, was injected a certain amount of medicine by given number of times applicable to discrete use in one day, perhaps, these devices are applicable to being connected continuously or the drug delivery of quasi-continuous ground by permanent fluid between explosive-feeding processing device and the patient.Last kind of means usually is called as a kind of pen device (a pendevice), and then a kind of means usually is called as injection pump." pen " device is a kind of device of making pen shape of machinery typically, yet it can have any configuration of wanting, and can comprise a motor such as it, with the injection of helping medicine.
Basically, syringe pump (or injection pump) can be divided into two kinds.First kind comprises durable syringe pump, and these pumps are relatively relatively more expensive, wish to use 3-4, and for this reason, the initial cost of this pump usually is an obstacle for such Therapeutic Method.Though compare more complicated with pen with traditional syringe, but this pump has following advantage: insulin injection continuously, strict and realize programmable drug delivery arrangement alternatively on the dosage, and with have a dinner control the batch injection (bolus infusions) of (or actuating) by user.In U.S. patent documents No.4562751 and No.4685903, provided the example of such pump, here that these patents are as a reference incorporated.In order to provide a kind of safe to the comfortable and firm pump of user; most of pumps are provided with a ventilating mechanism; make variation that pump can adapt to pressure (for example; because the internal part of motion; from the degassing of battery or the variation of ambient pressure); this ventilation is suitable for providing protection to a certain degree; entering of anti-sealing; for example see U.S. patent documents No.2004/0092873; it discloses a kind of injection device of outside; this device includes the housing of blow vent (or port), and this blow vent makes air can enter this housing and come out by this housing, and forbids that liquid enters housing by this blow vent.
In order to address the above problem, proposed several schemes second kind of medicament injection apparatus is provided, this installation cost is low, and is easy to use.Want to make some device in these devices partially or fully to become disposable, and wish that they can provide the advantage relevant with syringe pump, and do not have fringe cost and inconvenience, for example in advance filling pump, therefore avoid being full of or refilling medicine storage chamber.Known the example of such injection device by following patent document: by U.S. patent documents No.4340048 and No.4552561 (based on osmotic pumps), by U.S. patent documents No.5858001 (based on piston pump), by U.S. patent documents No.6280148 (based on membrane pump), by U.S. patent documents No.5957895 (based on current limliting pump (being also referred to as the bleed hole pump)), by U.S. patent documents No.5527288 (based on the aerogenesis pump) or by U.S. patent documents No.5814020 (based on the gel that can swell), all these devices have been proposed in the past few decades, as cheaply, mainly be disposable medicament injection apparatus, the file of being mentioned is as a reference incorporated.
Disposable pump generally comprises an installation surface with contact skin, it is suitable for being applied on the skin of object with adhering device, and use with injection needle, syringe needle is arranged such that thereby syringe needle stretches out the skin that penetrates object by the surface is installed under situation about using, when using this device, the position of syringe needle transdermal is covered.
When liquid medicine is offered user, user can check with the naked eye that medicine is extremely important, confirm that medicine does not have to confirm that perhaps any other visible variation has appearred in medicine, such as the oxidation of active medicine owing to for example from combination or infiltration crystallization or polymerization taking place.For insulin, these visible variations usually are called as " fibrillation ".Even the fibrillation of weak degrees may be serious for patient, because it may cause the anaphylaxis (allergy) to insulin potentially and change the time changing curve of insulin.
Be concerned about under the situation of prior art above-mentioned, an object of the present invention is to provide a kind of storage unit, it has and helps user to check the device of drug condition in a kind of safe and reliable mode, for example checks the fibrillation of insulin.
Summary of the invention
In the present disclosure of the invention, some embodiment and some aspects will be described, these embodiment and aspect will realize the one or more purposes in the above-mentioned purpose, and perhaps they will be realized by the following disclosure and the purpose that can obviously be realized by the description to exemplary embodiment.
Therefore, in first aspect, a kind of storage unit is provided, it comprises that is determined an inner housing, this housing comprises a transparent window portion, this window portion has inner surface, and storage unit also comprises a passage (or ventilation part), makes surrounding air and steam to pass through between the inside of housing and outside.A storage chamber is configured in enclosure interior, this storage chamber forms the inside that is suitable for comprising fluid medicine, this storage chamber comprises a transparent part, makes user to check medicine that at least a portion comprised by the transparent part of transparent window portion and storage chamber.This storage unit is suitable for second steady statue that first steady statues by 5 ℃ and 0-100% relative humidity (RH) carry out the transition to 40 ℃ and 75-100% relative humidity, and condenses without any visible water on the inner surface of window portion.This storage unit should be able to for example shift between two states in 5 seconds or 10 seconds apace.And then passage is suitable for providing 80% pressure balance being less than under the pressure reduction of 350mBar in the time of 60 minutes or 30 minutes between the inside of housing and outside, in order to ensure pressure-sensitive component can be suitable work.Like this, under any circumstance when being shifted out (for example in just by refrigerator with storage unit) can with the naked eye be checked the storage chamber and can not darkened by dew or agglomerative water droplet.Such operating position may be relevant with the storage unit of the pre-filling that comprises medicine, and this medicine need store under given low temperature, as under the situation of the medicine of for example insulin-containing.Because make the storage chamber between two states, shifts after, for example in by refrigerator, take out this unit in very short time afterwards user in most of the cases can check this storage chamber, so this storage unit is applicable to a predetermined interval for example 5 minutes, prevents from the inner surface of window portion, to occur visible water in 10 minutes or 30 minutes and condense.
Though " visible condensing " be a relative term seemingly, but think that this is a kind of clear and definite state that the ordinary people is easy to recognize, for example or formed bigger water droplet or formed visible dew, both of these case can produce and disturbs by window the storage chamber interior being carried out visual inspection.As an example, when forming dew on glass surface, the zone that has dew will very clearly be subjected to not forming relatively the peripheral region restriction of visible dew, and the ordinary people can identify two transition (or conversion) between the zone at an easy rate.
According to different embodiments of the invention, can realize preventing occurring on the inner surface of window portion visible water in many ways condenses, these modes perhaps can stop the water that has entered housing to condense on window for example for can postpone or stop water to enter housing.
A kind of storage unit, passage (or ventilation part) can postpone steam and enters enclosure interior under a given water vapour pressure difference therein, this storage unit can for example comprise a kind of limit steam by, enter housing inner thin film, the plunger that form is for example made for the material that is for example provided by Gore company by a kind of hydrophobic material be provided.Passage also can comprise a narrow pipeline, and it can make steam coagulation when the surrounding air of humidity enters the inside of housing, has stoped water to arrive to be configured in the housing parts than the position, deep like this.This pipeline can have any configuration of wanting, and particularly, it must not be piped, but any cross-sectional configuration can be arranged.Specifically, this term of pipeline is also included within quite flat space between two coplanar basically parts in presents.In order further to help water to condense, pipeline can comprise a part of condensing that is used as heat abstractor.For example, the part of pipeline can be arranged in be configured in shell intravital storage chamber or power supply near, when in the environment that storage unit is moved on to heat by colder environment, these two structures are as " cold " storage chamber.
A kind of storage unit, passage is suitable for stoping under a given water vapour pressure difference steam to enter the inside of housing therein, and this storage unit can for example comprise the valve of the pressure differential control between individual inside and the outside.In a further embodiment, passage can comprise molecular sieve, and water vapour will condense in molecular sieve, perhaps comprises the capillary tube that is suitable for the condensate water steam, the condensing this pipe of obstruction of water.A kind of pipeline in back (capillary tube) can combine with heat abstractor described above.In order to make passage can realize that it makes pressure balanced purpose, should make when second steady statue is transferred to by first steady statue in this unit agglomerative water for example be less than evaporation in 30 minutes in the relatively short time.
Correspondingly, in a preferred embodiment, a kind of storage unit of pocket-sized is provided, it comprises that is determined an inner housing, this housing comprises a transparent window portion, this window portion has inner surface, this storage unit also comprises a passage, it makes surrounding air and steam to pass through between the inside of housing and outside, this storage unit also comprises a storage chamber that is configured in enclosure interior, this storage chamber forms the inside that is suitable for comprising fluid medicine, and this storage chamber comprises a transparent part, makes the transparent part inspection medicine that at least a portion comprised that user can be by transparent window portion and storage chamber.Passage can form under the pressure reduction of 500mBar between the inside of housing and the outside and be lower than 7.5 liters/hour flow, is preferably lower than 5 liters/hour flow, preferably is lower than 2.5 liters/hour flow.The unit of pocket-sized can have less than 100 cubic centimetres, preferably less than 50 cubic centimetres volume.
Entered at steam under the situation of inside (perhaps allowing to enter housing) of housing, can prevent from the inner surface of window portion, to condense.Therefore for example, the spatial at least a portion between the transparent part of window portion and storage chamber can be sealed, stop steam to enter and possible condensing occur.In another embodiment, the inner surface of window portion can be provided with a coating, prevents from that water from condensing or preventing visible water to condense.A kind of scheme in back can realize that by a kind of coating of micropore this coating absorbs water and water is scatter from the teeth outwards.In another embodiment, provide a heating member, anti-sealing condenses on the inner surface of window, preferably heating member is configured near the window.
In the superincumbent disclosure; disclose for multiple indivedual solutions of avoiding the agglomerative problem of water; yet; in order to realize desirablely making housing ventilation and protect window portion the agglomerative purpose of water not occur simultaneously, can be in conjunction with two or more schemes of implementing in indivedual solutions.In fact, disclosed solution also can be used for being controlled at the water that enclosure interior occurs generally and condense, and for example may wish that preventing to occur on electronic unit water condenses.Except control steam enters, above-described passage also will stop fluid (for example water) and dust to enter inside.
The storage chamber can comprise the first and second deformable sheet segments, and these two parts are sealed together, and with the chamber that formation is sealed, is used for comprising fluid, the configuration of this storage chamber marsupial shape.
Storage unit can be provided with a fluid issuing and a discharge assembly, and this discharge assembly is suitable for and storage chamber collaborative work, to discharge fluid medicine by the storage chamber and by fluid issuing.A kind of structure represented in this term of employed outlet, and it will be used as outlet in the administration process of reality.In other words, when in fact not using, can be with this port closing.For example, the form of outlet can be the transparent barrier film of syringe needle, will close it, till syringe needle penetrates it.Outlet also can be provided with a valve, and this valve will get up port closing, till activating (or startup) administration discharger.
Such unit can further comprise the device (syringe needle for example of a transdermal, soft intubate, the micropin head array, traditional injection group or non-invasive transdermal (transdermal) device, under situation about using, these devices stretch out or are arranged on this lower surface by the lower surface that can be installed in the device on the skin), perhaps be suitable for device collaborative work with transdermal.This unit also can comprise an installation surface on the skin that is suitable for being applied to object, wherein, under situation about using, discharges the device that assembly is suitable for by transdermal and discharges medicine by storage chamber and the skin that passes object.
In one embodiment of the invention, a kind of medical treatment device is provided, it comprises device unit and an aforesaid storage unit of a transdermal, the device unit of transdermal comprises that the device of a transdermal and one are suitable for being applied to the installation surface on the skin of object, wherein, discharge assembly and be suitable for and store the chamber collaborative work, discharge fluid medicine with the device by transdermal by storage chamber and the skin that passes object, wherein, under situation about using, the device unit of transdermal and storage unit are suitable for together fixed to one another.These unit can comprise coupling arrangement, thereby can be so that these unit can be releasably together fixed to one another, and coupling arrangement is can the person of being to use activatable, for example comprises the one or more parts that can be handled, so that unclamp connection.
This medical treatment device only can be adapted such that and could check the storage chamber when the device unit of storage unit and transdermal is thrown off.
Employed here " medicine " this term meaning is to comprise any flowed medicine that comprises medicine, this medicine, and such as liquid, solution, gel, or thin suspension can be in a controlled manner by syringe needle or the intubate of doser such as hollow.Representational medicine comprises medicine, such as peptide, and protein (insulin for example, insulin analog, with the C-peptide), and hormone, biologically-derived dose or activating agent, based on the preparation of hormone and gene, nutrient formulation, and other material of solid (can provide and deliver) form or liquid form.In the description of exemplary embodiment, will be referred to the use of insulin.Correspondingly, " subcutaneous " injects this term and means any method that comprises for the transdermal administration of object.And then this term of syringe needle (when additionally not indicating) is defined as a piercing member that is used for penetrating the skin of object.
Description of drawings
Below, will further describe the present invention with reference to the accompanying drawings, in the accompanying drawings:
Fig. 1 shows an embodiment of modularity (or modular) explosive-feeding processing device with perspective view;
Fig. 2 shows the side view of the explosive-feeding processing device of assembling;
Fig. 3 shows a needle unit and storage unit of another embodiment that is used for explosive-feeding processing device with unassembled state;
Fig. 4 shows the other perspective view of the needle unit of Fig. 3;
Fig. 5 shows the perspective view of inside of the storage unit of Fig. 3;
Fig. 6 shows the exploded view of another kind of storage unit; And
Fig. 7 A-7D shows a plurality of embodiment of storage unit, and they comprise and prevent the agglomerative device of water.
In these accompanying drawings, represent identical structure with identical Reference numeral.
The specific embodiment
When using picture " above " and " below " below, " right side " and " left side " when " level " and " vertically " or similar relative expression, only is about accompanying drawing, rather than about the virtual condition of use.Shown figure is schematic expression, because this reason wishes that the configuration of different structure and the relative size in different structure only are used for illustrative purposes.
At first, referring to Fig. 1, will an a kind of embodiment of modular explosive-feeding processing device be described.Shown explosive-feeding processing device is an example of a kind of means, in such device, can advantageously realize one or more aspect of the present invention, yet, can combine with any relevant explosive-feeding processing device and adopt aspect of the present invention, in this device, wish to check the medicine feature.
The device unit 2 of transdermal (or through skin) comprises that a form is the device of the transdermal of syringe needle, therefore below it is called a needle unit, yet in narration of the present invention, its expression can be used for the device of any transdermal of drug delivery.
Needle unit comprises a base portion 10, and this is partly with one the surface is installed down, is suitable for being used on the skin of using user, comprises that also the injection needle (not shown) of 20, one hollows of a housing parts is configured in this housing parts.This syringe needle comprises a distal portions that is suitable for penetrating the skin of user, and a proximal part that is suitable for being configured to be in storage element the fluid connected state.The distal portions of syringe needle can move between an initial position and an extended position, and at initial position, this far-end is withdrawn with respect to the surface is installed, and in extended position, syringe needle stretches out with respect to exterior view is installed.And then syringe needle can move between extended position and retracted position, and in extended position, this far-end stretches out with respect to the surface is installed, and at retracted position, this far-end is with respect to the surface withdrawal is installed.Needle unit further comprises the actuating device that user can be caught, and its form is a strip- members 21,22, is used for respectively activating and retracted needle.Housing further comprises the coupling arrangement 40 of the activatable evagination of user, the form of this coupling arrangement is a pair of hook member that flexibly is provided with, its be suitable for storage unit on the collaborative work of corresponding indent connecting device, this makes and can releasably be fixed to storage unit on the needle unit under situation about using.Base portion comprises a quite firm top 11 that is attached on the more flexible bonding pieces of sheet 12, and this bonding thin slice has a following bonding surface, and described installation surface itself is provided, and this bonding surface is provided with strippable protection thin slice.Base portion also comprises a ridges 13, and it is suitable for engaging with a corresponding groove on the storage unit.
Fig. 2 shows storage chamber and the needle unit that is in assembled state, and syringe needle 30 is stretched out by its lower surface.
Fig. 3 shows basically another embodiment 500 with the corresponding medical treatment device of embodiment of Fig. 1, and this device comprises (patch-like) needle unit 502 of a cover plate shape and the storage unit 505 on it of being attached to of passage 510 is arranged.
Figure 4 illustrates the side of the needle unit 502 that is connected on the storage unit.Except two ridges 561 and the activatable coupling arrangement 511 of user, needle unit comprises further structure, and these structures are connected on the storage unit and/or with storage unit and engage, so that the functional interface with storage unit to be provided.More particularly, needle unit comprises the fluid intake that the sharp-pointed proximal part 532 by syringe needle provides, this proximal part is stretched out by needle unit, and be suitable for engaging with the fluid issuing of storage unit, needle unit also comprises an actuator 515, this actuator is stretched out by needle unit, and be suitable for engaging with a fluid connecting device in the storage unit, and activate this connecting device (promptly, between pump and storage chamber, realize that fluid is communicated with), needle unit also comprises the first and second contact activated devices 548,558, these actuators are suitable for engaging with corresponding contact on the storage unit.The part of the needle actuator that is stretched out by a perforate of passing in the housing provides the first contact activated device, and provides second actuator by a hinged portion that is connected to the housing on the needle retraction member.When at first being connected to needle unit on the storage unit, two contact activated devices will be stretched out by housing, and engage with corresponding contact on the storage unit, thereby demonstrate needle unit be coupled together.When making syringe needle be subjected to activating, the first contact activated device will be withdrawed from, thereby be disengaged, with the action (or actuating) of beginning pump with corresponding contact on the storage unit.When making syringe needle when withdrawal, the second contact activated device will pivot, and be disengaged with corresponding contact on the storage unit, to stop the action of pump.In fact, can many different modes make two interface configurations between the unit, it can provide different functions.For example, this system can be used for the placement or the actuating (or action) of syringe needle before storage unit is connected.
Fig. 5 shows the storage unit of top of housing having been removed.This storage unit comprises a storage chamber 760 and a discharge assembly, and this discharge assembly comprises a pump assembly 800 and control and actuating device 580,581.The pump assembly comprises the 822 and perforates 823 of an outlet that are used for being connected on the transcutaneous access device (for example syringe needle xxx), and this perforate makes and can the fluid connecting device of inside be activated.The form of storage chamber 560 is pre-that fill, flexible and bag that can collapse, and this bag comprises the barrier film that syringe needle can pierce through, and is suitable for this diaphragm cloth is set to pump assembly formation fluid being communicated with.Shown pump assembly is a mechanically actuated membrane pump, yet storage chamber and discharger can have any suitable configuration.Control and actuating device comprise a pump actuated piece, its form is a coil actuator 581, it is arranged to a piston of membrane pump is activated, control and actuating device also comprise a PCB or crooked (flex-print) parts of printing, one is used for controlling, except other, the microprocessor of the action of pump is connected on these parts, control and actuating device also comprise with needle unit on the contact 588 of contact activated device collaborative work, 589, be used for producing the signal generation device 585 of acoustical signal and/or haptic signal, optionally the display device (not shown) and the energy 586.The most handy thin film protects contact, and these thin film can be formed by the flexible portion of housing.Storage unit can further be provided with and receive and discharger, makes it possible to wirelessly this unit be controlled with remote control unit.
In Fig. 6, show the exploded view of the storage unit 505 of Fig. 3, this storage unit comprises a upper shell spare 507, a lower shell piece 509, this lower shell piece has a transparent zone 509 and holds the groove 504 of the ridges 561 that is stretched out by needle unit, this unit also comprises a flexibility storage chamber 760 that has the marginal portion 762 of rounding, diaphragm member 761 is installed on this marginal portion, this unit also comprises a pump assembly 800, and this pump assembly has actuator and is arranged on storage chamber top and comprises and be used for the wiring board (not shown) of electronic unit of actuating of control pump.
Further details and embodiment at the modular explosive-feeding processing device of the sort of type shown in Fig. 1-6 are disclosed in the applicant's patent document WO 2005/039673, here that this document is as a reference incorporated with its full text.
Referring to sketch map 7A-7D, there is shown four embodiment of storage unit at these, they comprise prevent to occur the agglomerative device of visible water on the inner surfacies of the window portion of storage unit.This storage unit is with reference to the disclosed the sort of type of figure 1-6, yet, for illustrative purposes, only show necessary those parts in core aspect of the different embodiment of explanation.
More specifically, Fig. 7 A shows a storage unit 100, and it comprises that forms a housing 101 of inner 102, and this housing comprises a transparent window portion 103 that inner surface is arranged.A storage chamber 150 is arranged in the inside of housing, this storage chamber forms the inside that is suitable for comprising fluid medicine, this storage chamber comprises a transparent part 151, makes that user can be by the transparent part inspection medicine that at least a portion comprised of transparent window portion and storage chamber.Shown storage chamber comprises the first and second deformable sheet segments, and these two parts are sealed together, and with the chamber that formation is sealed, is used for putting fluid, the configuration of this storage chamber marsupial shape, however can there be any configuration of wanting this storage chamber.The ventilation part that a form is set is vent plug 110 makes ambient air and steam to pass through between the inside of housing and outside.The remainder of this plunger and storage unit combines to be guaranteed in this plunger does not have to be less than under the pressure reduction at 350mBar when blocked time of 30 minutes to reach 80% pressure balance, the narration of face as follows between the inside of housing and outside.Simultaneously, the flux of this plunger control steam, make storage unit be suitable in the time that was less than for 5 seconds second steady statue that first steady statues by 5 ℃ and 0-100% relative humidity (RH) carry out the transition to 40 ℃ and 75-100% relative humidity (RH), and on the inner surface of window portion, condense without any visible water.
The hydrophobic plunger member of the sort of type that provided by Gore company for example is provided the vent plug type that the controlling the water circulation steam passes through of can exceeding.Provide the actual performance of the plunger member of desired functions will depend on a plurality of factors for given storage unit, such as the physical property of storage unit (size for example, material, parts are in the intravital spatial configuration of shell), the physical property that is used for limiting agglomerative other device of water that is provided also is provided.Model machine for realizing the principle of the invention has found that the thin film D3TV 911935 and the D3TV 911938 of Gore company can work satisfactorily.
Alternatively, vent plug 110 can be the type that stops steam to pass through, and this makes steam can condense in plunger.For example, plunger can comprise so-called molecular sieve, and this molecular sieve is a kind of microcellular structure, and hydrone will at first be retained down in molecular sieve, but make when plunger stands higher temperature that subsequently hydrone can evaporate.If the amount of steam is very big, the ability of the abundant ventilation of plunger may be lowered, till the plunger drying.In another kind of replacement scheme, vent plug can comprise a valve, controls this valve by pressure differential between inside and the outside.For example, this valve can be a passive valve, and it is suitable for opening under a given pressure differential (for example 50mBar), has found that for a kind of given pump this pressure differential can not disturb the function of storage unit.In fact, such solution is based on following hypothesis, promptly can not pressure differential between the inside of housing and outside and temperature difference all change suddenly.
A storage unit 200 has been shown in Fig. 7 B, and it has the general type identical with the storage unit of Fig. 7 A, and it comprises the housing 201 of a ventilation opening 210, transparent window portion 203, and a storage chamber 250.The ventilation part that to be provided with a form between the inside 202 of ventilation opening and housing be conduit 211.The airway type that the controlling the water circulation steam passes through of can exceeding, this by making at least a portion steam in this conduit, condense not blocks air by realizing.Alternatively, the ventilation part comprises a capillary vessel, and it is suitable for making steam coagulation, and this conduit is blocked in condensing of water, till agglomerative water is evaporated.
Two types conduit can combine with a heat abstractor 260, and this heat abstractor will be used for further reducing the temperature of the steam that enters, and therefore quicken condensing of water.For example, in a kind of given storage unit, also comprise a pump assembly and the energy that form is battery (or set of cells), this storage chamber and/or battery have relatively large thermmal storage ability, and this may can keep the longer time with low temperature than some parts in other parts of storage unit.In the exemplary embodiment, the surface portion of heat abstractor 3 volts of lithium batteries relatively large and be the part that planar outer surface can form conduit basically for example.
A storage unit 300 has been shown in Fig. 7 C, and it has the general type identical with the storage unit of Fig. 7 A, and it comprises 301, one transparent window portions 303 of housing of a ventilation opening 310, and a storage chamber 350.In order to prevent that steam enters the space of storing between chamber and the window portion when storage unit changes between first and second state, on the inner surface of window, condense thereupon, between storage chamber and window portion a sealing member 370 is set, the sealing part stops steam to enter this space.Sealing member can be the form an of sealing member that separates (for example O ring), and perhaps it can form with housing, as shown in the figure.Because agglomerative problem mainly with by taking out a new storage chamber in the cold storage device is associated, so can make sealing member only be suitable for engaging with the storage chamber (for example deformable bag shape storage chamber) of the shape variable that is in complete full state.
A storage unit 400 has been shown in Fig. 7 D, and it has the general type identical with the storage unit of Fig. 7 A, and it comprises 401, one transparent window portions 403 of housing of a ventilation opening 410, and a storage chamber 450.In order to prevent to condense on the inner surface of steam in window portion when storage unit changes between first and second state, the inner surface of window portion is provided with one deck coating 480, prevents from that water from condensing or preventing visible water to condense.In order further to help to stop water on window, to condense, a heating member 490 (requiring an energy, not shown) is set near window.Use in order to represent that above-described anti-sealing agglomerative different measure on window can combine together, the embodiment of Fig. 7 D further comprises vent plug 410 and conduit 411.
In two examples below, with the difference of performance between explanation embodiments of the invention and the traditional injection pump.
Example 1
Trial stretch: the condensation effects on manhole.
Test objective: with 15 storage units of general type identical in Fig. 6 and 7, that is, comprise a storage chamber and a manhole, remaining part is alternative with the false parts of representational heat storage capacity performance.With 2K Gore thin film all unit are installed, making to have the flow of 1.2l/h during for 500mBar in the inside of housing and the pressure differential between the surrounding air.
Test objective be by heat and environment humidity (temperature is+40 ℃, and relative humidity is 98%) shift-in cold with environment semi-humid (temperature is+5 ℃, and relative humidity is 75%), in 9 circulations of three days times.Adopt two climatic chambers: CI_ heat; Temperature is+40 ℃, and relative humidity is 98%, and CI_ is cold; Temperature is+5 ℃, and relative humidity is 75%.
Test circulation: (1) circulation beginning, (2) sample was placed in CI_ is cold 60 minutes, (3) sample was pined for placing 60 minutes at CI_, (4) condensation effects of observation on the inner surface of manhole, and (5) loop ends, get back to step 2,, sample is stayed CI_ pine for spending the night if carried out three circulations; Returned step 1 in the second day morning.
Moisture observations: test 9 circulations (3 circulations every day) according to the schedule that provides above.Do not observe steam in during 3 days.
Conclusion: because do not observe any steam, this test provides early stage prompting, and the scheme of protection water is feasible.This proof is exposed to the changeable temperature (between 5 ℃ and 40 ℃) of enough degree and the pump unit that is fitted with the 2K thin film of quite high humidity (98% relative humidity) and can prevents to occur condensing in inside, pump unit.
Example 2
Trial stretch: understand in the inside of the manhole of the insulin pump of routine condensation effects whether occurs.
Test objective: tested one and had and apply conduit
Pump.This pump comprises a manhole, can check a chuck by this window.This pump is equipped with thin film, and this thin film makes can the flow of 15.2l/h during for 500mBar in the inside of housing and the pressure differential between the surrounding air.
Test procedure: by heat and environment humidity (temperature is+40 ℃, and relative humidity is 98%) shift-in cold with environment semi-humid (temperature is+5 ℃, and relative humidity is 75%), carry out 9 circulations altogether three days times.Between each moving, under 20 ℃ and 75% relative humidity, inspection pump a few minutes.
Each circulation step: (1) circulation beginning, placed sample about 60 minutes (2) in cold environment, and (3) observed this sample 0.5-3 minute; If photo is taken in conglomeration (dough), placed sample about 60 minutes (4) in thermal environment, and (5) observed this sample 0.5-3 minute; If photo is taken in conglomeration, and (6) loop ends.At each point of observation, the outside of cleaning watch window is not condensed it.
Result: in during three days of test, begin to occur conglomeration by second day (perhaps by the 4th circulation).Conglomeration is positioned at window area in the position near vent membrane, and the area of the about 10-20 square millimeter of filling.During the 3rd day, by day during, the intensity of conglomeration increases.Under the environment of observation of 20 ℃ and 75% relative humidity, conglomeration can see 1-3 minute, then start vaporizer.After 1-3 minute, conglomeration disappears at last.
Conclusion: when in heat and wet environment for example in the Asia (temperature be+40 ℃, and relative humidity is 98%) pump storage 3 times time the in cold closet in 3 days is store between the chamber at manhole and insulin and conglomeration to be occurred.
In the description of preferred embodiments, described different structure and device that described function is provided for different parts to a certain extent in the above, under such degree, said for those skilled in the art, notion of the present invention will be clearly.Detailed structure and explanation those skilled in the art for different parts can finish the task that the normal design program realizes according to the route of presents narration.
Claims (23)
1. a storage unit (100,200,300,400), it comprises:
Determine inner housing, described housing comprises transparent window portion (103,203,303,403), and described window portion has inner surface;
Passage (110,211,310,411) makes surrounding air and steam to pass through between the inside of housing and outside;
Be arranged on the storage chamber (150 of the flexibility of enclosure interior, 250,350,450), described storage chamber defines with the pre-inside of filling of a kind of fluid medicine, described storage chamber comprises transparent part, makes that user can be by the transparent part inspection medicine that at least a portion comprised of transparent window portion and storage chamber;
Wherein, described storage unit is suitable for second steady statue that first steady statues by 5 ℃ and 0-100% relative humidity carry out the transition to 40 ℃ and 75-100% relative humidity, and condenses without any visible water on the inner surface of window portion; And
Wherein, described passage is suitable for reaching 80% pressure balance being less than under the pressure reduction of 350mBar in time of 60 minutes between the inside of housing and outside.
2. according to the described storage unit of claim 1, it is characterized in that described passage (110,211,310,411) is suitable for postponing the inside that steam enters housing under given water vapour pressure difference.
3. according to the described storage unit of claim 2, it is characterized in that described passage comprises thin film (110), described thin film restriction steam passes through, and enters the inside of housing.
4. according to the described storage unit of claim 2, it is characterized in that described passage comprises the narrow pipeline (211,411) that is suitable for the condensate water steam.
5. according to the described storage unit of claim 4, it is characterized in that described pipeline comprises that form is the part of condensing of heat abstractor (260).
6. according to the described storage unit of claim 1, it is characterized in that described passage (110) is suitable for stoping steam to enter the inside of housing under given water vapour pressure difference.
7. according to the described storage unit of claim 6, it is characterized in that described passage comprises the valve (110) by the control of the pressure differential between enclosure interior and the outside.
8. according to the described storage unit of claim 6, it is characterized in that described passage comprises molecular sieve (110), water vapour will condense in described molecular sieve.
9. according to the described storage unit of claim 6, it is characterized in that described passage comprises the capillary tube (211) that is suitable for the condensate water steam, the condensing of water with the described pipeline of obstruction.
10. according to claim 8 or 9 described storage units, it is characterized in that agglomerative water will evaporate being less than under second state in time of 30 minutes when described unit is moved on to second steady statue by first steady statue.
11., it is characterized in that the steam that prevents to enter the inside of described housing condenses according to the described storage unit of claim 1 on the inner surface of described window.
12. according to the described storage unit of claim 11, it is characterized in that, at least a portion space (370) between described window portion and the transparent storage chamber part sealed.
13., it is characterized in that the inner surface of described window portion is provided with coating (480) according to the described storage unit of claim 11, preventing that water from condensing or preventing visible water condenses.
14., it is characterized in that it also comprises heating member (490) according to the described storage unit of claim 11, anti-sealing condenses on the inner surface of described window portion.
15., it is characterized in that described heating member is configured near the inner surface of described window portion according to the described storage unit of claim 14.
16. according to each described storage unit in the aforementioned claim, it is characterized in that, it also comprises fluid issuing (822) and discharges assembly (800) that described discharge assembly is suitable for and described storage chamber collaborative work, to discharge fluid medicine by described storage chamber and by described fluid issuing.
17., it is characterized in that it also comprises according to the described storage unit of claim 16:
Be suitable for penetrating the device of transdermal of the skin of object; And
Be suitable for being applied to the installation surface on the skin of object;
Wherein, under situation about using, the device that described discharge assembly is suitable for by described transdermal is discharged medicine by storage chamber and the skin that passes object.
18. a medical treatment device, it comprises the device unit (2) of transdermal and according to the described storage unit of claim 16 (5), the device unit of described transdermal comprises:
The device of transdermal (30);
Be suitable for being applied to the installation surface on the skin of object;
Wherein, discharging assembly is suitable for discharging fluid medicine with the device of storage chamber collaborative work by described transdermal by storage chamber and the skin that passes object;
Wherein, under situation about using, the device unit of described transdermal and storage unit are suitable for together fixed to one another.
19. the storage unit of a pocket-sized (100), it comprises:
Determine inner housing, described housing comprises transparent window portion (103), and described window portion has inner surface;
Passage (110) makes surrounding air and steam to pass through between the inside of described housing and outside;
Be arranged on the storage chamber (150) of flexibility of the inside of described housing, described storage chamber defines with the pre-inside of filling of a kind of fluid medicine, described storage chamber comprises transparent part, makes that user can be by the transparent part inspection medicine that at least a portion comprised of transparent window portion and storage chamber;
Wherein, described passage can form under the pressure reduction at 500mBar between described housing inside and outside and be lower than per hour 7.5 liters flow.
20., it is characterized in that it also comprises fluid issuing (822) and discharge assembly (800) that described discharge assembly is suitable for and storage chamber collaborative work, discharges fluid medicine by described storage chamber and by fluid issuing according to the described storage unit of claim 19.
21., it is characterized in that it also comprises according to the described storage unit of claim 20:
Be suitable for penetrating the device of transdermal of the skin of object; And
Be suitable for being applied to the installation surface on the skin of object;
Wherein, under situation about using, the device that described discharge assembly is suitable for by transdermal is discharged medicine by storage chamber and the skin that passes object.
22. a medical treatment device, it comprises the device unit (2) of transdermal and according to the described storage unit of claim 20 (5), the device unit of described transdermal comprises:
The device of transdermal (30);
Be suitable for being applied to the installation surface on the skin of object;
Wherein, discharging assembly is suitable for discharging fluid medicine with the device of storage chamber collaborative work by described transdermal by storage chamber and the skin that passes object;
Wherein, under situation about using, the device unit of described transdermal and storage unit are suitable for together fixed to one another.
23. according to each described storage unit among the claim 19-22, it is characterized in that, described passage can form under the pressure reduction of the inside of described housing and the 500mBar between the outside and be lower than 5 liters/hour or be lower than 2.5 liters/hour flow, and wherein, the volume of storage unit is less than 100 cubic centimetres, perhaps less than 50 cubic centimetres.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP05109630.3 | 2005-10-17 | ||
| EP05109630 | 2005-10-17 | ||
| PCT/EP2006/067483 WO2007045644A1 (en) | 2005-10-17 | 2006-10-17 | Vented drug reservoir unit |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101291697A CN101291697A (en) | 2008-10-22 |
| CN101291697B true CN101291697B (en) | 2011-05-18 |
Family
ID=35464131
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2006800386481A Expired - Fee Related CN101291697B (en) | 2005-10-17 | 2006-10-17 | Vented drug reservoir unit |
Country Status (5)
| Country | Link |
|---|---|
| US (2) | US20080287870A1 (en) |
| EP (1) | EP1940489A1 (en) |
| JP (1) | JP2009511223A (en) |
| CN (1) | CN101291697B (en) |
| WO (1) | WO2007045644A1 (en) |
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| WO2009013734A2 (en) * | 2007-07-20 | 2009-01-29 | Medingo Ltd. | Energy supply for fluid dispensing device |
| WO2013049180A1 (en) * | 2011-09-27 | 2013-04-04 | Animas Corporation | Water resistant drug infusion housing with pressure differential sensor |
| WO2014187432A1 (en) * | 2013-05-20 | 2014-11-27 | Tao Kai | Video iv monitor |
| US9457141B2 (en) * | 2013-06-03 | 2016-10-04 | Bigfoot Biomedical, Inc. | Infusion pump system and method |
| US9987416B2 (en) * | 2015-01-09 | 2018-06-05 | BioQuiddity Inc. | Sterile assembled liquid medicament dosage control and delivery device |
| US11338082B2 (en) | 2019-09-04 | 2022-05-24 | BloQ Pharma, Inc. | Variable rate dispenser with aseptic spike connector assembly |
| KR102367650B1 (en) * | 2019-11-01 | 2022-02-28 | 김용현 | Medicinal liquid supply regulating apparatus and medicinal liquid injection apparatus including the same |
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Also Published As
| Publication number | Publication date |
|---|---|
| CN101291697A (en) | 2008-10-22 |
| US20080287870A1 (en) | 2008-11-20 |
| EP1940489A1 (en) | 2008-07-09 |
| WO2007045644A1 (en) | 2007-04-26 |
| US20110160670A1 (en) | 2011-06-30 |
| US8394060B2 (en) | 2013-03-12 |
| JP2009511223A (en) | 2009-03-19 |
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